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Friday, August 30, 2019

It’s been almost
three weeks since my last update which means that there is a massive amount of
material to cover and I can’t get to it all in this little update.

If you want to
check out all of the links that I have aggregated over the past three weeks, go
over to https://www.adcdaily.com/ and click on the ADC Links Section Header.In these posts I just aggregate all of the
relevant links that I find before winnowing down for these update
articles.But it you want to quickly see
anything and everything that I thought was related to ADCs, then this is the
place.

While you’re there, click on the list to join the mailing list, and
then you can get every post directly to your inbox.We had quite a few people join after the last
posting, so come join the cool kids and gets your ADCDaily posts automatically.

And one last thing.I am
excited to announce that I will be hosting a Webinar next month.It will be chock full of ADCs and DoEs.I will do my best not to get too excited, but
I most certainly love geeking out with DoEs and we have some pretty cool case
studies planned for you.It’s being held
on Sep 24th at 11 EST.Hope
to see you all there.

Statement on data accuracy issues with recently approved gene therapyFDA
- It's never a good thing when you have to have a direct statement about your work from Dr. Peter Marks, the Director of CBER at the FDA. But here is a perfect reason why it is better to read articles from the original source instead of the news aggregators viewpoint. This line sticks out, "The FDA is carefully assessing this situation and remains confident that Zolgensma should remain on the market." It sounds to me like there are taking the issue seriously, but that when the dust settles, things are going to be OK for Zolgensma even though there are clearly going to be some casualties along the way

How Biotech Startup Funding Will Change in the Next 10 YearsYCombinator Blog
- Alright, so lets take this one with a big grain of salt. As I often say, never ask a barber if you need a haircut. However, this is an interesting take on the potential future of biotech. Although there is the inherit difference in that YC makes apps and algorithms while we make complex chemicals for use in even more complex systems and that will always be true. You don't see YC startups trying to upend Exxon or Anheiser-Busch because it took them 100 years to build the distribution network that they currently have, and the VC model doesn't have that kind of patience

Road Tripping TreatmentsAbbVie Blog
- Here is another example of non-oncology ADCs. The team at AbbVie spent five years researching an application of ADCs in immune-mediated diseases. After 100 different linkers and 200 different payloads they finally have a candidate. This is a cool story, and some really incredible work

Araris Biotech AG closes seed financing round of CHF 2.5 millionGlobal Newswire
- It's time to welcome a newcomer to the ADC world. Araris has closed their seed round and they are looking to develop their own ADCs using a proprietary conjugation technology which can be applied to native antibodies. Hopefully this is just the first of many positive news stories

The evolving role of trastuzumab emtansine (T-DM1) in HER2-positive breast cancer with brain metastasesCritical Reviews in Oncology/Hematology
- Here is a nice review of Kadcyla in patients with brain metastases. Apparently HER2 overexpression isn't just a positive indication for Kadcyla, but it also comes with an increased chance for brain metastases. And, as we know, ADCs cannot get beyond the blood-brain barrier to be effective. However, despite this, Kadcyla has proven partially effective in these patients. Maybe the reason isn't clear, but it is definitely interesting

Other - Pig to human heart transplants 'possible within three years'The Guardian
- This is just really cool. I also like how their microRNA treatment was able to restore heart cells damaged from the heart attack to"almost complete recovery" after a month, but then follows that up with, "most of the treated pigs died after the treatment because the microRNA-199 continued to be expressed in an uncontrolled way." Oops

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Thats it for today. There are always more coming down the pike. Is there something I missed? Contact me. Justin@ADCDaily.com
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Wednesday, August 7, 2019

It's
time again for another update on the world of ADC. There's been lots of good
stuff happening as always in our industry and I'm excited to put some
highlights below for you to take a look at.

But
before we start with that, I have been working on making it easier to get these
updates to you without completely relying on you checking your LinkedIn feed.
So if you are interested, I have set up an email newsletter service through my
blog site.

So
if you want to sign up, click on that box on the left hand column of this page.

And
lastly, thank you again for taking the time to read these articles. It seems
like I wasn't the only one feeling like an ADC news roundup would be useful. So
if you like these and want more, please like, comment, or reshare them because
every time you do, it makes it that much easier for me to convince my boss that
this is a worthwhile use of my time. And now, on to the good stuff...

1.
Video of ADC killing mouse cells

Ok,
I know that I already shared this on LinkedIn, but it is just that cool. I have
watched this video dozens of times. And when the cells explode like balloons
it's just too cool. Maybe this isn't the newsiest thing, but it definitely will
add some pep to your step when you get into lab next.

**Side
note: I've also watched the video while only looking at the left side of the
screen, and that alone is still amazing.

2.
New Frontiers in ADC Development

This
article is a bit of a longer read, but this is what happens when you get a
bunch of the strongest voices in ADCs together to talk about their industry.
Tons of good insight and predictions. A realistic look at the industry today as
well as some thoughts on where the industry has failed to meet expectations.
The article isn't short, but is worth the time for sure.

When asked what successes ADCs
have had, Chris Martin (ADC Therapeutics CEO replied, "Great drugs
are built on the shoulders of good drugs, and the progression over the
last five years...is a testament to this."

The author asked the panel what
are ADCs biggest challenges going forward, and it was fascinating to see
how different and varied every answer was depending on their backgrounds
and current roles.

And when asked what the future
holds, the responses ranged from new combination therapies, and
payload/linker technologies, to non-oncology applications and expansion of
the current marketing authorizations.

3.
A pair of articles for my fellow ADC nerds out there

There
were two articles that I came across that got my mind running. The first is a
comprehensive report of the application of different mass spec technologies to
ADC characterization.

To
be fair, as a process guy, I don't really understand all of the specifics and
nuances that this article covers, but I can tell this is something worth taking
a look at for anyone who can properly spell Triple Quad LC-MS/MS

The
second article is actually a white paper put out by Innate Pharma trying to
sell some aggregation standards.

The
short version is that they used their aggregate standard to test a bunch of
different conjugates. The cool part is where they were able to use the
Temperature of Aggregation (Tagg) as a proxy for aggregation propensity. The
paper looks at this on the final product, but it's also potentially a very cool
assay that could be helpful in process development. Has anyone played with
this to see how process changes can affect ADC stability? I'd be
interested to see how this can apply not only across multiple constructs like
they look at, but at different times during conjugation. Specifically,
around cysteine reduction.

4.Market Reports

Maybe
someone out there can help me with this one. As I spend a significant amount of
time each week curating all of the interesting stories that I can find about
ADCs I invariably come across an incredibly large number of these ADC Market
Reports. Here are some examples from the last two weeks alone:

And
I have links to at least 6 more of these. All looking the exact same. All
telling the same thing. All announcing great and immense growth in the upcoming
years. Each one is published by a different company, but they are all asking
for ~$3280 for access to the PDF report. Who is buying these things? And how
can there possibly be so many? Maybe this is the Pharma market equivalent of
the Nigerian prince who wants you to hold onto his money for him.

This
is the first article in this edition of the journal Drugs. It is the science
journal version of a montage on the approval of Polivy. So if you want to see
the entire package wrapped into a nice little story, look no further.

I
know this isn't about ADCs, but if you're like me, you spend an extraordinary
amount of time paying attention to ADCs but only hear tangentially about Gene
Therapy and its goings-on. So, for those of us who aren't as informed as
we might like, the New England Journal of Medicine put together a fantastic
report.

Justin's
Thoughts:

Putting
together these news summaries has been a lot of fun so far, and there is
another idea I have been interested in, but I need your help. Instead of
putting together a summary of the latest news, I have been interested in diving
a little deeper on a specific topic and trying to put something together that
is a little more holistic on one specific area of ADCs.

All
of that being said, here is the part where we switch to a choose your own
adventure novel. Below are a couple of topic areas I have been thinking about.
Vote for your favorite in the comments section below, and I will get working on
writing up the winner. And as a second check that this is actually interesting
to anyone, I'll say the threshold for a go story will be 20 votes.

Reports - Gene TherapyNew England Journal of Medicine
- I know this isn't about ADCs, but if you're like me. You spend an extraordinary amount of time paying attention to ADCs but only hear tangentially about Gene Therapy and its goings-on. So, for thos of us who aren't as informed as we might like, the New England Journal of Medicine put together a fantastic reportClinical Results - Phase I safety and pharmacokinetics study of rovalpituzumab tesirine in Japanese patients with advanced, recurrent small cell lung cancerLung Cancer
- Rova-T is not dead yet. Well, to be fair, I don't know. But at least this report says that Japanese patients exhibited tolerable toxicity and saw partial response rates of 17%. They conclude that this is worth further investigation, but that doesn't necessarily mean there will be